22
Apr

FDA says its recent QSR amendment will streamline the path to market for medical device providers.

GET EXPERT ADVICE AT MEDTECH FORUM 2022 After four years in the works, the U.S. Food and Drug Administration (FDA) has finally published their much-anticipated proposed rule (PR) to amend the Quality System Regulation (QSR) (21 CFR Part 820) on 2/23/2022. This proposed rule not only impacts U.S. manufacturers but all manufacturers with product in […]

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09
Feb

Frances Zipp to Moderate WiHP Healthcare Leadership Luncheon at AAM Annual Meeting

Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]

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09
Feb

Frances Zipp to Moderate WiHP Healthcare Leadership Luncheon at AAM Annual Meeting

Join Frances Zipp, President and CEO of Lachman Consultant Services, Inc., at the AAM Annual Conference, Access! 2022, where she will moderate the WiHP Healthcare Leadership luncheon. The panel discussion will be held on February 15, 2022, at 12:30 pm. Frances will be joined by AMCP CEO Susan Cantrell, AHIP’s EVP of Government Affairs and […]

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07
Dec

Just in Case You Couldn’t Attend – The Lachman Learning Experience Data Integrity Webinar

Data integrity is an ever-increasing concern in the life sciences as evidenced by the recent activities of the FDA placing its watchful eye on the evolving medical device industry. To help manufacturers better understand, establish, and maintain data integrity under growing regulatory scrutiny, Lachman Consultant Services, Inc. (Lachman Consultants) hosted a free webinar on Wednesday, […]

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04
Nov

Tune in to GRx+Biosims 2021 All Access Podcast Special Featuring Lachman Consultant’s Bob Pollock

Join Lachman Consultant Services, Inc. (Lachman Consultants) at the GRx+Biosims 2021 virtual event for three days of timely insights, peer networking, and unique content geared toward technical, regulatory, and policy professionals in the U.S. generics and biosimilars industry. Held from November 8 – 10, the widely acclaimed event will bring together top officials and subject-matter […]

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01
Nov

Join Lachman Consultants in Boston at the ISPE Annual Meeting & Expo— and Enter to Win an Apple Watch

We are pleased to announce that Lachman Consultants will once again participate in the ISPE Annual Meeting & Expo. This event will be held at the Hynes Convention Center in Boston, MA, from October 31 – November 3, Booth #1033. Lachman attendees include: Fran Zipp, President and CEO Linda Evans O’Connor, Vice President, Chief of […]

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06
Oct
Hospital

FDA Issues Revised Guidance on Hospital and Healthcare Systems Compounding

Today, the FDA issued a third revision of a draft guidance titled Hospital and Health System Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act (here).  The Agency revised this guidance, which was previously revised in June 2016, in response to comments submitted to that document.  The revised document describes how and […]

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06
Oct

Annual Medicines for Europe and IGBA Conference

The Key Role of Off Patent Medicines: Fran Zipp, President and CEO of Lachman Consultant Services, Inc., will be a moderator on Session- 6 OFF-PATENT ROLE FOR GLOBAL HEALTH: PUTTING PATIENTS FIRST, at the Annual Medicines for Europe and IGBA Conference in Athens, Greece on October 6-8, 2021. The agenda includes bridging the access gap […]

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18
Nov

Lachman Consultants Named “Top-Ten Medical Device Consulting Company” by Med-Tech Outlook

(Westbury, NY— November 2020) Lachman Consultant Services, Inc. (Lachman Consultants), a provider of compliance, regulatory, and technical consulting services to the global pharmaceutical and related industries, was recently named a “Top-Ten Medical Device Consulting Company” by highly-regarded, industry publication MedTech Outlook. In making the announcement in its September issue, the monthly periodical outlined that its […]

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